This presentation quickly reviews the industry changes of the recent past by taking a snapshot of the biotech industry in 1997 versus its current growing importance of the industry in 2010.

Also the current business challenges will be covered and the way innovative improvements in technology can create competitive advantages for a biopharmaceutical company.

A forward look into drivers of change in society, regulatory, product scale mix, and environment on the impact to fill finish and container systems. A glimpse into possible future state fill finish and container systems.

Small batches of pharmaceutical and biopharmaceutical products intended to be sterile present several challenges to the manufacturing and quality assurance systems in place for larger scale and commercial operations.  

Through their Training and Research Institute, PDA has several training courses intended to provide the knowledge and expertise to address these challenges.  

A small scale manufacturing  facility at the PDA Bethesda headquarters provides students a hands-on opportunity to put their newly acquired knowledge into practice without risk to in-company facilities and operations. 

This presentation will address the training opportunities available.

Advanced Barrier Technologies in Aseptic Processing; give a basis for the introduction of recent draft guidelines and case studies for application of RABS and Isolator technology at BI.

As an expert in the prefilled injection systems industry, Mr. Puterbaugh will underscore the importance of collaboration and partnership in contract manufacturing, and will discuss how Vetter Pharma has responded to the particular industry needs in the areas of biotech drugs, clinical trials and small batches.

This session will review what helps to identify a possible contract manufacturing organization for you discussing universal principles, with an emphasis on prefilled injection systems.

He will also describe how Vetter has incorporated the most advanced aseptic filling technologies targeted at supporting customer's clinical candidates and expensive drugs by focusing on disposable technologies and minimized drug substance losses.

The pharmaceutical market is moving towards complex and specialized drugs where manufacturing small-scale commercial batches on flexible production is mandatory in providing more effective treatments targeting specific diseases.

Time to market and shorten development cycles are key factors in driving the investments of new drug developments.

This paper illustrates an integrated packaging solution in a standard format. Leveraging from the experience of nest & tub prefilled syringes, EZ-fill vials and cartridges are ideal for Isolator/RABS production and biotech products; the concept covers the growing trend to choose combined packaging and devices.

Fill/finsh technologies for small batches is becoming more and more important for the future. Requirements like small footprint, flexibility comobined with fully automated process handling drives the machine solutions and design.

Current requiremetns include handling of nested pre-sterilized syringes, vials as well as cartridges on the same fill/finish machines.

These requirements will be addressed at the presentation and will show machine solutions for small batch handling.

The production of sterile drug products has significantly evolved in the past decades with the emergence of ready to sterilize and ready to use packaging components.

Fill & finish operations still face challenges related to product quality, compliance trends and process optimization. They can be managed by bringing container closure integrity earlier in the manufacturing process.

Along with ready to use component, implementation of LyoSeal technology offers means to decrease the number of steps of fill & finish operation to a new minimum.